Summary

The primary objective of this study is to obtain implant survivorship and clinical outcomes
data for commercially available Persona fixed bearing knee implants used in total knee
arthroplasty. The assessment will include implant survivorship and clinical performance
measured by pain and function, quality of life data, radiographic parameters and
survivorship.

Study Design

Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System

zimmer persona total knee system
Primary Knee Replacement,

Primary Outcomes

Measure

Knee Society Scores

time frame:
5 years post op

Secondary Outcomes

Measure

EQ-5D

time frame:
5 years post op

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria:
- Patient 18-75 years of age, inclusive;
- Patient qualifies for primary total knee arthroplasty based on physical exam and
medical history, including diagnosis of severe knee pain and disability due to at
least one of the following:
- rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis;
- collagen disorders and/or avascular necrosis of the femoral condyle;
- post-traumatic loss of joint configuration, particularly when there is
patellofemoral erosion, dysfunction or prior patellectomy;
- moderate valgus, varus, or flexion deformities;
- the salvage of previously failed surgical attempts that did not include partial
or total knee arthroplasty of the ipsilateral knee;
- Patient has participated in a study-related Informed Consent process;
- Patient is willing and able to complete scheduled study procedures and follow-up
evaluations;
- Independent of study participation, patient is a candidate for commercially available
Persona fixed bearing knee components implanted in accordance with product labeling.
Exclusion Criteria:
- Patient is currently participating in any other surgical intervention studies or pain
management studies;
- Previous history of infection in the affected joint and/or other local/systemic
infection that may affect the prosthetic joint;
- Insufficient bone stock on femoral or tibial surfaces;
- Skeletal immaturity;
- Neuropathic arthropathy;
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the
affected limb;
- Stable, painless arthrodesis in a satisfactory functional position;
- Severe instability secondary to the absence of collateral ligament integrity;
- Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent
breakdown of the skin;
- Patient has a known or suspected sensitivity or allergy to one or more of the implant
materials;
- Patient is pregnant or considered a member of a protected population (e.g., prisoner,
mentally incompetent, etc.);
- Patient has previously received partial or total knee arthroplasty for the
ipsilateral knee.

Additional Information

Official title

Persona Outcomes Led Assessment Research in Total Knee Arthroplasty

Description

The study design is a prospective, multicenter, study of the commercially available Persona
fixed bearing knee implants. The study will require each site to obtain Institutional Review
Board (IRB) approval prior to study enrollment. All potential study subjects will be
required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee
arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at
6 weeks, 6 months, 1 year, 2, 3, 4, and 5 years.

Trial information was received from ClinicalTrials.gov and was last updated in November 2016.